Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 7:12 PM
Study NCT ID:
NCT04950660
Status:
COMPLETED
Last Update Posted:
2025-02-21
First Post:
2021-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Oral Caffeine Use for Pain Management in AIS Patients After Spinal Fusion
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D002110', 'term': 'Caffeine'}], 'ancestors': [{'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'astuedemann@cmh.edu', 'phone': '8162343693', 'title': 'Anne Stuedemann MSN, RN, CPNP', 'organization': "Children's Mercy Kansas City"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2-5 days postoperatively', 'description': 'There were no documented complications, adverse events, or adverse drug reactions related to caffeine usage in this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Caffeine Arm', 'description': 'Experimental Group: patient group (n =24) receiving a 100 mg dose of caffeine (1/2 of a 200mg tablet to be taken whole or crushed), taken twice daily. This will be an adjuvant to their standard pain control.\n\nCaffeine Tablet: Caffeine is approved by the FDA as a stimulant. A stimulant approved by the United States Food and Drug Administration (FDA) for the treatment to increase mental alertness and in combination with painkiller to treat migraine headaches. It is approved in the form of pill or tablet.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Arm', 'description': 'Control group: patient group (n =27) receiving placebo compounded to look similar to the caffeine treatment, taken twice daily. This will be an adjuvant to their standard pain control.\n\nCaffeine Tablet: Caffeine is approved by the FDA as a stimulant. A stimulant approved by the United States Food and Drug Administration (FDA) for the treatment to increase mental alertness and in combination with painkiller to treat migraine headaches. It is approved in the form of pill or tablet.\n\nPlacebo: Placebo, empty opaque dark blue blank capsule, taken twice daily. This will be an adjuvant to their standard pain control.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Post Operative Oral Morphine Milligram Equivalents (MME)/Kilogram (Kg) for Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caffeine Arm', 'description': 'Experimental Group: patient group (n = 24) receiving a 100 mg dose of caffeine (1/2 of a 200mg tablet to be taken whole or crushed), taken twice daily. This will be an adjuvant to their standard pain control.\n\nCaffeine Tablet: Caffeine is approved by the FDA as a stimulant. A stimulant approved by the United States Food and Drug Administration (FDA) for the treatment to increase mental alertness and in combination with painkiller to treat migraine headaches. It is approved in the form of pill or tablet.'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Control group: patient group (n = 27) receiving placebo compounded to look similar to the caffeine treatment, taken twice daily. This will be an adjuvant to their standard pain control.\n\nCaffeine Tablet: Caffeine is approved by the FDA as a stimulant. A stimulant approved by the United States Food and Drug Administration (FDA) for the treatment to increase mental alertness and in combination with painkiller to treat migraine headaches. It is approved in the form of pill or tablet.\n\nPlacebo: Placebo, empty opaque dark blue blank capsule, taken twice daily. This will be an adjuvant to their standard pain control.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.83', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '0.92', 'spread': '0.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'For hospital stay up to 7 days', 'description': 'Total Post Operative Oral Morphine milligram equivalents (MME)/kilogram (Kg) for Hospital Stay', 'unitOfMeasure': 'MME/Kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Daily Verbal Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caffeine Arm', 'description': 'Experimental Group: patient group (n = 24) receiving a 100 mg dose of caffeine (1/2 of a 200mg tablet to be taken whole or crushed), taken twice daily. This will be an adjuvant to their standard pain control.\n\nCaffeine Tablet: Caffeine is approved by the FDA as a stimulant. A stimulant approved by the United States Food and Drug Administration (FDA) for the treatment to increase mental alertness and in combination with painkiller to treat migraine headaches. It is approved in the form of pill or tablet.'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Control group: patient group (n =27) receiving placebo compounded to look similar to the caffeine treatment, taken twice daily. This will be an adjuvant to their standard pain control.\n\nCaffeine Tablet: Caffeine is approved by the FDA as a stimulant. A stimulant approved by the United States Food and Drug Administration (FDA) for the treatment to increase mental alertness and in combination with painkiller to treat migraine headaches. It is approved in the form of pill or tablet.\n\nPlacebo: Placebo, empty opaque dark blue blank capsule, taken twice daily. This will be an adjuvant to their standard pain control.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.33', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '3.51', 'spread': '1.48', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'For hospital stay up to 7 days', 'description': 'Utilizing Verbal Analog Scale 0-10, 0 being no pain and 10 being severe pain', 'unitOfMeasure': 'Units on a scale/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Heart Rate During Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caffeine Arm', 'description': 'Experimental Group: patient group (n = 24) receiving a 100 mg dose of caffeine (1/2 of a 200mg tablet to be taken whole or crushed), taken twice daily. This will be an adjuvant to their standard pain control.\n\nCaffeine Tablet: Caffeine is approved by the FDA as a stimulant. A stimulant approved by the United States Food and Drug Administration (FDA) for the treatment to increase mental alertness and in combination with painkiller to treat migraine headaches. It is approved in the form of pill or tablet.'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Control group: patient group (n = 27) receiving placebo compounded to look similar to the caffeine treatment, taken twice daily. This will be an adjuvant to their standard pain control.\n\nCaffeine Tablet: Caffeine is approved by the FDA as a stimulant. A stimulant approved by the United States Food and Drug Administration (FDA) for the treatment to increase mental alertness and in combination with painkiller to treat migraine headaches. It is approved in the form of pill or tablet.\n\nPlacebo: Placebo, empty opaque dark blue blank capsule, taken twice daily. This will be an adjuvant to their standard pain control.'}], 'classes': [{'categories': [{'measurements': [{'value': '78.8', 'spread': '10.3', 'groupId': 'OG000'}, {'value': '83.8', 'spread': '12.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'For hospital stay up to 7 days', 'description': 'Documented heart rates which are then averaged over 24 hours', 'unitOfMeasure': 'Beats per minute/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Systolic Blood Pressure During Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caffeine Arm', 'description': 'Experimental Group: patient group (n = 24) receiving a 100 mg dose of caffeine (1/2 of a 200mg tablet to be taken whole or crushed), taken twice daily. This will be an adjuvant to their standard pain control.\n\nCaffeine Tablet: Caffeine is approved by the FDA as a stimulant. A stimulant approved by the United States Food and Drug Administration (FDA) for the treatment to increase mental alertness and in combination with painkiller to treat migraine headaches. It is approved in the form of pill or tablet.'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Control group: patient group (n = 27) receiving placebo compounded to look similar to the caffeine treatment, taken twice daily. This will be an adjuvant to their standard pain control.\n\nCaffeine Tablet: Caffeine is approved by the FDA as a stimulant. A stimulant approved by the United States Food and Drug Administration (FDA) for the treatment to increase mental alertness and in combination with painkiller to treat migraine headaches. It is approved in the form of pill or tablet.\n\nPlacebo: Placebo, empty opaque dark blue blank capsule, taken twice daily. This will be an adjuvant to their standard pain control.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.3', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '101.4', 'spread': '6.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'For hospital stay up to 7 days', 'description': 'Documented systolic blood pressures which are then averaged over 24 hours', 'unitOfMeasure': 'mmHg/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Caffeine Arm', 'description': 'Experimental Group: patient group (n = 34) receiving a 100 mg dose of caffeine (1/2 of a 200mg tablet to be taken whole or crushed), taken twice daily. This will be an adjuvant to their standard pain control.\n\nCaffeine Tablet: Caffeine is approved by the FDA as a stimulant. A stimulant approved by the United States Food and Drug Administration (FDA) for the treatment to increase mental alertness and in combination with painkiller to treat migraine headaches. It is approved in the form of pill or tablet.'}, {'id': 'FG001', 'title': 'Placebo Arm', 'description': 'Control group: patient group (n = 34) receiving placebo compounded to look similar to the caffeine treatment, taken twice daily. This will be an adjuvant to their standard pain control.\n\nCaffeine Tablet: Caffeine is approved by the FDA as a stimulant. A stimulant approved by the United States Food and Drug Administration (FDA) for the treatment to increase mental alertness and in combination with painkiller to treat migraine headaches. It is approved in the form of pill or tablet.\n\nPlacebo: Placebo, empty opaque dark blue blank capsule, taken twice daily. This will be an adjuvant to their standard pain control.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Poor pain control, switch to Oxycodone', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Hypotension', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Caffeine Arm', 'description': 'Experimental Group: patient group (n = 34) receiving a 100 mg dose of caffeine (1/2 of a 200mg tablet to be taken whole or crushed), taken twice daily. This will be an adjuvant to their standard pain control.\n\nCaffeine Tablet: Caffeine is approved by the FDA as a stimulant. A stimulant approved by the United States Food and Drug Administration (FDA) for the treatment to increase mental alertness and in combination with painkiller to treat migraine headaches. It is approved in the form of pill or tablet.'}, {'id': 'BG001', 'title': 'Placebo Arm', 'description': 'Control group: patient group (n = 34) receiving placebo compounded to look similar to the caffeine treatment, taken twice daily. This will be an adjuvant to their standard pain control.\n\nCaffeine Tablet: Caffeine is approved by the FDA as a stimulant. A stimulant approved by the United States Food and Drug Administration (FDA) for the treatment to increase mental alertness and in combination with painkiller to treat migraine headaches. It is approved in the form of pill or tablet.\n\nPlacebo: Placebo, empty opaque dark blue blank capsule, taken twice daily. This will be an adjuvant to their standard pain control.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.25', 'spread': '1.5', 'groupId': 'BG000'}, {'value': '14.81', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '14.55', 'spread': '1.43', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '53.8', 'spread': '8.2', 'groupId': 'BG000'}, {'value': '54.72', 'spread': '7.1', 'groupId': 'BG001'}, {'value': '54.29', 'spread': '7.56', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Did not measure combined weight'}, {'title': 'Complications', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Operative Time', 'classes': [{'categories': [{'measurements': [{'value': '230.92', 'spread': '49.6', 'groupId': 'BG000'}, {'value': '246.15', 'spread': '43.4', 'groupId': 'BG001'}, {'value': '238.98', 'spread': '46.58', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Minutes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of Segments Fused', 'classes': [{'categories': [{'measurements': [{'value': '9.92', 'spread': '2.1', 'groupId': 'BG000'}, {'value': '10.52', 'spread': '1.9', 'groupId': 'BG001'}, {'value': '10.24', 'spread': '1.98', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Number of segments', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-08-27', 'size': 888715, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-27T14:08', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'This study will be a prospective, randomized control trial and will be double-blinded, with the patient, provider, and researcher blinded to the treatment.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study will be a prospective, randomized control trial and will be double-blinded, with the patient, provider, and researcher blinded to the treatment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2021-06-15', 'resultsFirstSubmitDate': '2025-01-08', 'studyFirstSubmitQcDate': '2021-06-25', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-31', 'studyFirstPostDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Post Operative Oral Morphine Milligram Equivalents (MME)/Kilogram (Kg) for Hospital Stay', 'timeFrame': 'For hospital stay up to 7 days', 'description': 'Total Post Operative Oral Morphine milligram equivalents (MME)/kilogram (Kg) for Hospital Stay'}], 'secondaryOutcomes': [{'measure': 'Mean Daily Verbal Analog Scale (VAS)', 'timeFrame': 'For hospital stay up to 7 days', 'description': 'Utilizing Verbal Analog Scale 0-10, 0 being no pain and 10 being severe pain'}, {'measure': 'Average Heart Rate During Hospital Stay', 'timeFrame': 'For hospital stay up to 7 days', 'description': 'Documented heart rates which are then averaged over 24 hours'}, {'measure': 'Average Systolic Blood Pressure During Hospital Stay', 'timeFrame': 'For hospital stay up to 7 days', 'description': 'Documented systolic blood pressures which are then averaged over 24 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adolescent Idiopathic Scoliosis']}, 'descriptionModule': {'briefSummary': 'Prospective, randomized control trial To determine if oral caffeine decreases the frequency of opioid demand in children with adolescent idiopathic scoliosis after their spinal fusion surgery To compare pain scale ratings, number of requests for diazepam, average heart rate, average blood pressure, sex, age, ethnicity, post-op day of discharge, operative time, estimated intraoperative blood loss, remittance post-surgery, length of hospital stay, and segments fused during spinal fusion surgery.', 'detailedDescription': "Because these receptors are so important for modifying pain and inflammation, caffeine has been added as an adjuvant to common analgesics, such as paracetamol, ibuprofen, and aspirin in the belief that it will enhance their analgesic efficacy. Most studies used paracetamol or ibuprofen with 100 mg to 130 mg caffeine, and the most common pain conditions studied were postoperative dental pain, postpartum pain, and headache. There was a small but statistically significant benefit with caffeine used at doses of 100 mg or more, which was not dependent on the pain condition or type of analgesic. Additionally, trials have shown superior efficacy of adding caffeine to ibuprofen instead of administering ibuprofen alone for treating acute pain, reflecting that caffeine is an effective analgesic adjuvant. The addition of caffeine (≥ 100 mg) to a standard dose of commonly used analgesics provides a small but important increase in the proportion of participants who experience a good level of pain relief.\n\nFinally, the beneficial effects of caffeine on aerobic activity and resistance training performance are well documented. Studies have shown that caffeine ingestion resulted in significantly lower levels of soreness compared with placebo (p ≤ 0.05). A further beneficial effect of sustained caffeine ingestion in the days after the exercise bout is an attenuation of delayed onset muscle soreness. Orthopaedic surgery also causes muscle injury, and patients might benefit from caffeine's effect on lowering muscle soreness. Acute caffeine administration also has been shown to demonstrate increases in alertness, contentment, motivation to work, talkativeness, and energy. It also decreases muscle twitches. All of these effects would be beneficial in the post-operative period, especially for Adolescence Idiopathic Scoliosis (AIS) patients undergoing spinal fusion surgery in the orthopaedic department at Children's Mercy Hospital."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* must meet criteria for surgical correction of scoliosis\n* must be able to swallow pills\n* must have English as a primary language\n* must possess mental capacity to understand purpose of the study\n* patient must carry diagnosis of adolescent idiopathic scoliosis\n* surgery must be performed via posterior approach\n* operation performed by either Dr. John T. Anderson, Dr. Richard M. Schwend, Dr. Aaron Shaw, Dr. Michael Benvenuti\n* post-surgical AIS patients from June 2019-June 2024\n* the patient must be between the ages of 12 and 17 years old\n* the patient and one of their biological parents or guardian(s) must give consent for patient to be included in this study\n* Negative Suicide screen\n\nExclusion Criteria:\n\n* obesity, as defined by a BMI at or above the 95th percentile\n* weight below 40 kg\n* any orthopedic diagnosis other than AIS\n* revision spine surgery\n* anterior or combined approach\n* admission to PICU post-op\n* use of Oxycodone post-op\n* allergies to ibuprofen, caffeine, codeine, or diazepam\n* history of renal disease\n* history of a coagulation disorder\n* history of cardiac dysrhythmia or open heart surgery\n* history of Chronic Pain Syndrome or Complex Regional Pain Syndrome\n* current use of oral central nervous system stimulant (e.g. methylphenidate)\n* Positive Suicide screen\n\nThe following populations will be excluded:\n\n* Children over the age of 18, or turning 18 during time of surgical treatment\n* Children or parents unable to consent\n* Individuals with cognitive delays\n* Pregnant females\n* Prisoners\n* Wards of the state'}, 'identificationModule': {'nctId': 'NCT04950660', 'briefTitle': 'Oral Caffeine Use for Pain Management in AIS Patients After Spinal Fusion', 'organization': {'class': 'OTHER', 'fullName': "Children's Mercy Hospital Kansas City"}, 'officialTitle': 'Oral Caffeine Decreases the Frequency of Opioid Demand in AIS Patients After Spinal Fusion', 'orgStudyIdInfo': {'id': 'STUDY00000775'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Caffeine arm', 'description': 'Experimental Group: patient group (n = 34) receiving a 100 mg dose of caffeine (1/2 of a 200mg tablet to be taken whole or crushed), taken twice daily. This will be an adjuvant to their standard pain control.', 'interventionNames': ['Drug: Caffeine Tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo arm', 'description': 'Control group: patient group (n = 34) receiving placebo compounded to look similar to the caffeine treatment, taken twice daily. This will be an adjuvant to their standard pain control.', 'interventionNames': ['Drug: Caffeine Tablet', 'Drug: Placebo']}], 'interventions': [{'name': 'Caffeine Tablet', 'type': 'DRUG', 'otherNames': ['Caffeine'], 'description': 'Caffeine is approved by the FDA as a stimulant. A stimulant approved by the United States Food and Drug Administration (FDA) for the treatment to increase mental alertness and in combination with painkiller to treat migraine headaches. It is approved in the form of pill or tablet.', 'armGroupLabels': ['Caffeine arm', 'Placebo arm']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Blank'], 'description': 'Placebo, empty opaque dark blue blank capsule, taken twice daily. This will be an adjuvant to their standard pain control.', 'armGroupLabels': ['Placebo arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64114', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children'S Mercy Hospitals & Clinic", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'overallOfficials': [{'name': 'Anne S Stuedemann, APN, MSN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "CHILDREN'S MERCY HOSPITALS & CLINICS"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'only the research team will have access to study results. No IPD will be shared with anyone outside of the research team.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Mercy Hospital Kansas City", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'APRN III', 'investigatorFullName': 'Anne Stuedemann', 'investigatorAffiliation': "Children's Mercy Hospital Kansas City"}}}}